Bortezomib and Gemcitabine in Treating Patients With Relapsed Mantle Cell Lymphoma

August 3, 2023 updated by: NCIC Clinical Trials Group

A Phase II Study of Bortezomib and Gemcitabine in Patients With Relapsed Mantle Cell Lymphoma

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may help gemcitabine work better by making cancer cells more sensitive to the drug.

PURPOSE: This phase II trial is studying how well giving bortezomib together with gemcitabine works in treating patients with relapsed mantle cell lymphoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the efficacy (response rate) of bortezomib and gemcitabine hydrochloride in patients with relapsed mantle cell lymphoma.
  • Determine the toxicity of this regimen in these patients.
  • Determine the time to progression and duration of response in patients treated with this regimen.

OUTLINE: This is a nonrandomized, multicenter study.

Patients receive bortezomib IV on days 1, 4, 8, and 11 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter until relapse/progression.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BCCA - Vancouver Cancer Centre
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • QEII Health Sciences Center
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • QEII, CCR, Hematology Research
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Juravinski Cancer Centre at Hamilton Health Sciences
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Program
      • Toronto, Ontario, Canada, M4N 3M5
        • Odette Cancer Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • Univ. Health Network-Princess Margaret Hospital
    • Quebec
      • Montreal, Quebec, Canada, H2W 1S6
        • McGill University - Dept. Oncology
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatoon Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed mantle cell lymphoma

    • Relapsed disease

  • Not refractory to prior therapy

    • Must have received 1-3 prior systemic chemotherapy regimens AND has had no disease progression while receiving chemotherapy or within 1 month of last dose of most recent therapy

  • Clinically and/or radiologically documented disease

    • At least 1 site of disease must be bidimensionally measurable by CT scan or MRI with ≥ 1 lesion meeting 1 of the following criteria:

      • Lymph nodes ≥ 1.5 cm x 1.5 cm by spiral CT scan
      • Non-nodal lesion ≥ 1 cm x 1 cm by MRI, CT scan, or physical exam
    • No nonmeasurable disease only
  • No preexisting ascites or pleural effusion ≥ grade 2
  • No known CNS involvement by lymphoma

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 12 weeks
  • Absolute granulocyte count ≥ 1,500/mm³
  • Platelet count ≥ 75,000/mm³
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • AST or ALT ≤ 2.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • LVEF ≥ 45% by echocardiogram or MUGA
  • No history of allergic reactions attributed to compounds containing boron or mannitol
  • No preexisting edema ≥ grade 2
  • No preexisting neuropathy (sensory and/or pain) ≥ grade 2
  • No preexisting shortness of breath ≥ grade 2
  • No history of other malignancies, except adequately treated nonmelanoma skin cancer, curatively treated in situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years

  • No other serious illness or medical condition that would preclude compliance with study requirements, including any of the following:

    • Serious uncontrolled infection

    • Uncontrolled or severe cardiovascular disease, including any of the following:

      • Myocardial infarction within the past 6 months
      • New York Heart Association class III-IV heart failure
      • Uncontrolled angina
      • Clinically significant pericardial disease
      • Cardiac amyloidosis
    • Significant neurological disorder

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 6 weeks since prior chemotherapy
  • No prior radioactive monoclonal antibody therapy
  • No prior bortezomib
  • No prior investigational therapy (except for flavopiridol)
  • No prior radiotherapy to > 25% of functioning bone marrow

  • At least 4 weeks since prior radiotherapy and recovered

    • Low-dose, nonmyelosuppressive radiotherapy may be allowed
  • At least 2 weeks since prior major surgery
  • No other concurrent anticancer therapy
  • No concurrent corticosteroids
  • No other concurrent cytotoxic chemotherapy
  • No other concurrent investigational agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bortezomib + Gemcitabine
Drug: bortezomib
1.0 mg/m2 IV; injection bolus (3-5 sec) Twice weekly x 2 weeks every three weeks
Drug: gemcitabine hydrochloride
1000 mg/m2 IV; injection 30 minute infusion Once weekly x 2 weeks every three weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective tumor response (overall response rate with 95% confidence interval)
Time Frame: each cycle
each cycle
Time to progression at median time
Time Frame: each cycle and every 3 months after treatment
each cycle and every 3 months after treatment
Duration of response (median and range)
Time Frame: each cycle and every 3 months after treatment
each cycle and every 3 months after treatment
Rate of stable disease and progressive disease
Time Frame: each cycle and every 3 months after treatment
each cycle and every 3 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NCIC Clinical Trials Group

Investigators

  • Principal Investigator: C. Tom Kouroukis, MD, Margaret and Charles Juravinski Cancer Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2007

Primary Completion (Actual)

April 21, 2009

Study Completion (Actual)

June 21, 2011

Study Registration Dates

First Submitted

September 13, 2006

First Submitted That Met QC Criteria

September 13, 2006

First Posted (Estimated)

September 15, 2006

Study Record Updates

Last Update Posted (Actual)

August 4, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I172
  • CAN-NCIC-IND172 (Registry Identifier: PDQ)
  • ORTHO-CAN-NCIC-IND172 (Other Identifier: Ortho Biotech)
  • CDR0000493021 (Other Identifier: PDQ)
  • B9E-CA-0485 (Other Identifier: Lilly)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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